- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00123318
A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
It has been shown recently in a study conducted in the USA (INT0116) that postoperative, adjuvant chemoradiotherapy improves survival for patients with gastric cancer. This treatment is relatively new and there remains debate regarding the optimal chemotherapy regimen and the optimal method of radiotherapy delivery. This study will evaluate a new regimen of adjuvant chemoradiotherapy for gastric cancer that employs ECF chemotherapy as the systemic component given before and after concurrent chemoradiation with continuous infusional 5-fluorouracil. Patients receive one cycle of ECF, followed 28 days later by chemoradiotherapy to a radiation dose of 45 Gy in 25 fractions over 5 weeks, and then one month later two further cycles of ECF are given. All patients are treated using multiple-field conformal radiation techniques.
The specific objectives of the study are:
- To detail the acute toxicity associated with this treatment.
- To determine the feasibility of the proposed concurrent chemoradiation regimen.
- To determine the feasibility of a standardized technique for radiation treatment planning and delivery.
The study will help to develop a common approach to the adjuvant treatment of gastric cancer, which is required before initiating further clinical trials in gastric cancer.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 3
Kontakte und Standorte
Studienorte
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New South Wales
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Liverpool, New South Wales, Australien, 1871
- Liverpool Hospital
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Newcastle, New South Wales, Australien, 2298
- Calvary Mater Newcastle
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Penrith, New South Wales, Australien, 2751
- Nepean Cancer Care Centre
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Randwick, New South Wales, Australien, 2031
- Prince of Wales Hospital
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Sydney, New South Wales, Australien, 2145
- Westmead Hospital
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Sydney, New South Wales, Australien, 2050
- Royal Prince Alfred Hospital
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Sydney, New South Wales, Australien, 2069
- Royal North Shore Hospital
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Queensland
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Brisbane, Queensland, Australien
- Mater QRI
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Herston, Queensland, Australien, 4029
- Royal Brisbane Hospital
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Tugun, Queensland, Australien, 4224
- East Coast Cancer Centre
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Woolloongabba, Queensland, Australien, 4102
- Princess Alexandra Hospital
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Tasmania
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Launceston, Tasmania, Australien, 7250
- Launceston General Hospital
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Victoria
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Box Hill, Victoria, Australien
- Box Hill Hospital
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Geelong, Victoria, Australien, 3220
- Andrew Love Cancer Care Centre, Geelong Hospital
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Melbourne, Victoria, Australien, 3081
- Austin Health
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Melbourne, Victoria, Australien, 8006
- Peter MacCallum Cancer Centre
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Prahran, Victoria, Australien, 3181
- Alfred Hospital
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Western Australia
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Perth, Western Australia, Australien, 6009
- Sir Charles Gairdner Hospital
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-
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Christchurch, Neuseeland, 4710
- Christchurch Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
All of the following must apply:
Histologically proven adenocarcinoma of the stomach or gastro-oesophageal junction that is:
- completely resected with negative margins
- Stage T3,4 and/or N1,2 patients who have undergone a D2 nodal dissection can be entered on the study at the discretion of the treating clinician.
- Age greater than or equal to 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2
Adequate organ function defined as follows:
- Bone marrow: Haemoglobin greater than or equal to 90 g/L; Neutrophil count greater than or equal to 1.5 x 10^9 /L; Platelet count greater than or equal to 100 x 10^9 /L
- Hepatic: Serum bilirubin less than or equal to 1.5 x ULN; AST and/or ALT less than or equal to 3.0 x ULN;
- Renal: Serum creatinine less than or equal to 0.150 mmol/L, and calculated creatinine clearance greater than or equal to 50mL/min.
- Adequate oral nutrition (intake greater than or equal to 1500 calories/day). This is to be assessed by a dietician prior to commencing treatment.
- Disease which can be radically treated to 45 Gy with standard fractionation.
- Patient able to be treated with infusional 5-fluorouracil (5-FU) and ECF chemotherapy.
- Written informed consent
Exclusion Criteria:
None of the following must apply:
- Evidence of metastatic disease.
- Prior chemotherapy or radiotherapy
- Patients with other significant underlying medical conditions that may be aggravated by the study treatment or are not controlled.
- Pregnant or lactating females or female patients of childbearing potential who have not been surgically sterilized or are without adequate contraceptive measures.
Cardiac failure (relevant to the use of epirubicin):
- Patients with myocardial infarction within the last 6 months;
- Patients with New York Heart Association class III/IV congestive heart failure
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 1
Single-arm, non-randomised feasibility study to evaluate new regimen of adjuvant chemoradiotherapy (Epirubicin, Cisplatin, 5-Fluorouracil + radiotherapy)
|
50mg/m2 IV day 1
Andere Namen:
60mg/m2 IV day 1
Andere Namen:
5-FU 200mg/m2/d IV 21 day continuous infusion Cont.
infusional 5-FU 225mg/m2/day, 7 days/wk throughout entire period RT via CADD pump through PICC line
Andere Namen:
45Gy 25 Fractions, 5 days/week for 5 weeks
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
The percentage of patients who develop grade 3 or grade 4 haematological and gastrointestinal acute toxicity
Zeitfenster: Final analysis will be at 3 years.
|
Final analysis will be at 3 years.
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The percentage of patients who complete the planned chemoradiation protocol
Zeitfenster: Final analysis will be at 3 years.
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Final analysis will be at 3 years.
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The percentage of major radiotherapy protocol violations
Zeitfenster: Final analysis will be at 3 years.
|
Final analysis will be at 3 years.
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Median survival and overall survival at 3 years
Zeitfenster: 3 years
|
3 years
|
Mitarbeiter und Ermittler
Ermittler
- Studienstuhl: Trevor Leong, Peter MacCallum Cancer Centre, Australia
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Verdauungssystems
- Neubildungen
- Neubildungen nach Standort
- Gastrointestinale Neubildungen
- Neoplasmen des Verdauungssystems
- Magen-Darm-Erkrankungen
- Magenerkrankungen
- Magenneoplasmen
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Enzym-Inhibitoren
- Antimetaboliten, antineoplastisch
- Antimetaboliten
- Antineoplastische Mittel
- Immunsuppressive Mittel
- Immunologische Faktoren
- Topoisomerase-II-Inhibitoren
- Topoisomerase-Inhibitoren
- Antibiotika, antineoplastische
- Cisplatin
- Fluorouracil
- Epirubicin
Andere Studien-ID-Nummern
- TROG 03.02
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